Results Announced for Abdominal Bulge Injection Treatment

Results announced for abdominal bulge injection treatment

Neothetics announced results from its AbCONTOUR1 and AbCONTOUR2 Phase 3 trials which evaluated the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat.

The results showed that LIP-202 failed to meet the co-primary composite and secondary endpoints while showing benign safety profile. The established endpoints were the proportion of patients who reported an improvement of ≥1 point on the Patient-Global Abdominal Perception Scale (P-GAPS) and an improvement of ≥2 points on the Clinician Photonumeric Scale (CPnS), and those who reported a ≥2 improvement on both scales.

The trial included a total of 1584 patients, who received either a weekly 0.4mcg dose of LIPO-202 or placebo for 8 weeks.

“We are disappointed by these unequivocally negative results. We expected LIPO-202 to demonstrate better efficacy based on the results we saw in the Phase 2b RESET trial,” said George Mahaffey, President and Chief Executive Officer of Neothetics.

LIPO-202 is an injectable formulation of salmeterol xinafoate, a ß2-adrenergic receptor agonist. Neothetics' studies suggest that salmeterol xinafoate activates ß2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink by means of lipolysis.